The invention relates to a breast prosthesis with a flexible plastic body comprising two plastic sheets connected to each other along their common edge and a plastic mass enclosed between the two plastic sheets, wherein the plastic body has a front side formed to resemble the shape of the natural breast and a back side capable of facing the torso of the wearer, and an elastically deformeable thin part secured with its edge to the back side of the plastic body. The invention also relates to a method for making the breast prosthesis. Breast prosthesis of this type are worn in bras, bikini tops, swimsuits and the like.
A breast prosthesis of this type is known from DE 44 21 516 C1. The state of the art provides a breast prosthesis which is very comfortable to wear and has a natural appearance. Since breast prosthesis are often worn for a long time and in addition simulate a part of the body which is very important for the self esteem of the woman, even slight improvements in the wear comfort and in the simulation of the natural appearance, respectively, represent a significant progress.
It is the object of the invention to design the breast prosthesis in such a way that the wear comfort and the simulation of the natural appearance, respectively, are further improved, as well as to provide a method for the manufacture thereof.
Since the prosthesis in the edge regions preferably only includes the plastic sheets enclosing the plastic mass, an almost continuous or natural transition between the prosthesis and the skin of the wearer can be achieved. This advantage of the embodiment of the invention is particularly evident when fabric material is used for the thin part, since the thickness of the fabric material requires a stepped transition.
Some wearers prefer to wear the breast prosthesis directly on their skin. With the embodiment of the invention, the risk that the prosthesis slips is reduced, which could otherwise make an unnatural and thus undesirable impression. Here, the edge portion of the prosthesis is not covered by the thin part which is made preferably of fabric material, and advantageously has a larger friction coefficient than the thin part when it makes contact with the skin of the wearer. This effect is enhanced by the natural moistness of the skin.
After partial amputations or after reconstruction of a new, but smaller breast after a full amputation, cup prosthesis are preferably used which only simulate the contour of a portion of the natural breast. In order to provide a transition between the remaining or reconstructed breast and the prosthesis which appears as natural and continuous as possible, the thickness of the plastic body of such cup prosthesis usually decreases towards the edge. As a result, the thickness and thus the stiffness of the flexible plastic body is reduced in comparison to a full prosthesis. According to the invention, the possibility for the edge of the plastic body to curl up as a result of the force created by the tension of the thin part is reduced, since the thin part is displaced towards the inside. The plastic body is therefore at most dented, but never curls. The deformation is further reduced by the increased wall thickness of the plastic body and the increased stiffness resulting therefrom. Preferably, the thin part is secured to the back side of the plastic body 1 to 4 cm inside the edge of the breast prosthesis. This distance can vary, preferably with the size of the breast to be simulated and with the point of attachment.
Preferably, an opening is provided in the thin part and/or between the thin part and the plastic body for inserting filler material between the thin part and the back side of the breast prosthesis. In this way, the prosthesis can be individually fitted to the upper body, i.e. to the remaining breast or to the breast to be reconstructed, respectively. In particular, changes can be accommodated. In addition, the wearer herself can adjust the position of the filler material by trial and error for providing a better wear comfort and fit of the prosthesis.
Preferably, the thin part is deep drawn in such a way that a tensionless fit with the concave form of the back side of the plastic body is provided, which has the advantage that the thin part also contacts without tension the breast tissue which is left or remains intact after a partial amputation, thereby providing enhanced wear comfort.
It is another advantage of the breast prosthesis of the invention that it can be used as a cup evening out a breast, both for a breast reduction and for a breast enlargement. Furthermore, the breast prosthesis can easily be adapted to the changing volume and weight of the breast during the course of a step-by-step reconstruction through a step-by-step reduction of the filler material.
On the breast prosthesis of the invention, the thin part is secured to the plastic body inside the common edge of the plastic sheets connected to each other. In this way, the thin part is located closer to the front part of the breast or, expressed differently, farther inward of the breast prosthesis. Furthermore, a material can advantageously be selected for the thin part which is molded not at all or only slightly during the deep drawing process, but which is elastic enough so that the thin part essentially regains the same surface area it had before the deep drawing process. This creates an area with only slight tension. In first approximation, the breast prosthesis of the invention can then be regarded as an elastic hollow body. If a force is applied to an elastic hollow body as to compress it in one direction, then the cross sectional area between the delimiting surfaces increases. This enlargement is, for example, greatest for a cylinder or a sphere at their respective centers. If the envelope of the hollow body is connected along the cross sectional area, then the connection means will also be distorted when the cross sectional area increases. The force necessary to accomplish this opposes the compressing force. In addition to the rigidity residing in the envelope, the body is reinforced by connecting means opposing the increase in cross section.
In a breast prosthesis of the invention of this type, the plastic body is at its attachment line reinforced by the thin part, in addition to having its own rigidity. With the same stiffness, the breast prosthesis can thus be constructed to have less weight, whereby the wear comfort is enhanced. In addition, the breast prosthesis can be manufactured less expensively. Depending on the requirement for and the size of the breast to be simulated, one, two or more thin parts can be connected to the plastic body. Through a suitable selection of the number and the placement of the thin parts, the breast prosthesis can be optimally fitted to resemble the features of the natural breast. Satisfactory results are achieved with a first thin part in the rearward third and a second thin part in the forward third of the breast prosthesis.
In order to increase the wear comfort for women who do not desire a direct contact between the plastic sheet of the breast prosthesis and their skin, the thin part closest to the torso of the wearer is preferably enlarged by a marginal section extending to the common edge of the plastic sheets, wherein the marginal section contains preferably microfibers.
Advantageously, the outer edge of the marginal section is joined to the plastic body using the same method which is used for connecting the two plastic sheets. This can be accomplished by welding or gluing. The fixed connection between the outer edge of the marginal section and the plastic body allows the outer edge exactly to be even with the edge of the plastic sheets. An overhanging edge which could protrude from the garment under which the breast prosthesis is worn, is thereby avoided.
The marginal section of the thin part is advantageously joined to the back side facing the torso of the wearer in form of a grid pattern. This can, for example, be done by a welding operation using a tool having a grid pattern. A secure and slip-free fit of the thin part and consequently of the breast prosthesis is thereby ensured. Also reduced is the danger that the breast prosthesis slides and thereby causes unnatural effects.
The breast prosthesis contacts the torso of the wearer only along the marginal region. The sensitive skin and scar tissue are to a large extent ventilated, thereby accelerating for a freshly amputated wearer the scarring process and promoting an environment which does not irritate the skin. The continuous movement on the body causes a suction and pump effect which ensures an exchange of air between the skin and the prosthesis.
Placement of the thin part inside the edge of the plastic body creates a cavity capable of receiving breast tissue which is left after a partial amputation, without causing a troublesome pressure contact between the thin part and the remaining breast tissue. If, however, more breast tissue can be saved during a partial amputation than the cavity is capable of receiving without creating a contact between the breast tissue and the thin part, then the remaining breast tissue presses less strongly against the thin part than is the case with a breast prosthesis where the thin part is secured to the edge of the plastic body.
Preferably, the thin part is made of a microfiber or a climatic fabric. Since sweat in the form of steam can penetrate such material, but is prevented from returning to the skin of the wearer when in condensed form, the skin remains comfortably dry even under considerable bodily exertion.
Instead of joining the thin part to the plastic body by welding, the thin part can also be glued to the plastic body. Gluing also provides a secure and durable connection between the parts. The material should be secured by gluing if the material selected for the thin part cannot be welded at all or only with great difficulty, for example, when the material is made entirely or in part of a natural fiber, such as cotton.
Welding the thin part to the plastic body does not necessarily mean that the thin part completely fuses together with the plastic body. In this specification, the term xe2x80x9cweldingxe2x80x9d shall also describe an attachment method wherein the thin part only fuses with the adjacent plastic sheet of the plastic body at its respective surface.
A variety of different materials can be used for the thin part. The major criteria for selecting the material to be used for the thin part is that the material can be easily attached to and released from the plastic body, and must have a desired elasticity and stiffness, respectively, a high tear resistance, good ability to absorb and release moisture, a comfortable softness and must be easy to clean. If the thin part is to be welded to the plastic body, then the thin part is preferably made of polyamide or polyester fibers. The thin part can be made at least in the marginal region of cotton or of a mixture of polyamide and/or polyester fibers and cotton because these materials are known for not irritating the skin. If the thin part should be capable of transporting the moisture away from the skin surface, then the thin part is advantageously a woven or knitted fabric made of microfibers which is pervious to moisture in the form of steam, but prevents condensated moisture from permeating. Particularly suited are extremely fine fibrillated microfibers made of polyester and polyamide. Such microfiber fabrics are known in the art as xe2x80x9cclimate fabricsxe2x80x9d. The different sections can be made of different materials depending on the different requirements. For example, the front thin part in particular preferably comprises a plastic sheet made of, for example, polyurethane.
Preferably, in the breast prosthesis there is provided an opening for inserting filler material into the cavity located between the tensioned surface(s) and the back side facing the torso of the wearer. The opening is preferably reclosable, in particular using a Velcro closure. The opening can be provided in the weld seam between the thin part and the back side facing the torso of the wearer or in the thin part itself. The filler material is preferably a padding element, in particular a microfiber thread ball or an air-tight film ball or a foam element. The opening is advantageous in that the padding element can be removed and enlarged.
The opening for filling the breast prosthesis preferably includes an element for reinforcing the fabric edges. For this purpose, there is disposed between the fabric member and the fabric tape a plastic sheet which is welded or glued to the fabric member and the fabric tape. Thereby a laminate comprising the fabric member, the fabric tape and the plastic sheet is created at the marginal region of the fabric member, wherein the laminate reliably protects the edge of the fabric member and also the edge of the fabric tape from fraying, can be manufactured economically, is not or is only marginally thicker than the fabric member and the fabric tape when both the fabric member and the fabric tape are superposed, and wherein the laminate does not change the appearance of the fabric member or the appearance of the fabric tape.
Preferably, the plastic sheet(s) is (are) polyurethane films which can be made very thin, extremely elastic and transparent and can be welded well to the fabric member and the fabric tape.
In addition, the fabric member and the fabric tape can be made of the same material, preferably of a fabric made of polyamide or polyester fibers, whereby the adhesion between the plastic sheet and the fabric member and the adhesion between the plastic sheet and the fabric tape is identical.